ECRI Identifies Unintended Consequences of FDA's Proposed UDI Rule

The Food and Drug Administration (FDA)’s final rule on Unique Device Identification (UDI) is scheduled for release in May 2013. ECRI Institute, an independent nonprofit that researches the best approaches to improving patient care, announces its submission of official comments to the FDA.

ECRI Institute believes that UDI is a good idea and although it fully supports its intent, the organization says it is concerned about some unintended and costly consequences that could affect everyone involved with healthcare facilities and the supply chain.

If implemented correctly, UDI should help healthcare organizations do a better job of tracking and managing their inventories of medical devices. This can help control costs, achieve better standardization, and identify product safety concerns. Patient safety and product development researchers should be able to better identify trends in device problems and develop early safety warnings and product design improvements. However, in order for UDI to achieve its expected benefits, it needs to be based on solid, sustainable, and accessible naming conventions and database design structures.

ECRI Institute says it is concerned that FDA’s UDI design will not achieve these goals because the rule is based on a single medical device naming convention—one which has not been publicly available for general review and commentary. More importantly, the ECRI Institute adds that it has been used by only a very small number of healthcare organizations and medical device manufacturers in the United States, and does not have a publicly available model for how it will be technically and financially maintained and updated over time.